This trial will test if a cooling probe can protect the oesophagus during ablation, reducing the risk of severe oesophageal damage in AF patients.
- Atrial Fibrillation
- Atrio-Esophageal Fistula
1 Primary · 6 Secondary · Reporting Duration: Measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.
2 Treatment Groups
1 of 2
1 of 2
500 Total Participants · 2 Treatment Groups
Primary Treatment: Study group · No Placebo Group · N/A
Who is running the clinical trial?
Age 18 - 85 · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Leung LWM, Gallagher MM. Letter in reply to Gianni et al on "Prevention, diagnosis, and management of atrioesophageal fistula". Pacing Clin Electrophysiol. 2020 Nov;43(11):1417-1418. doi: 10.1111/pace.14012. Epub 2020 Sep 3.
- Leung LW, Gallagher MM, Santangeli P, Tschabrunn C, Guerra JM, Campos B, Hayat J, Atem F, Mickelsen S, Kulstad E. Esophageal cooling for protection during left atrial ablation: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2020 Nov;59(2):347-355. doi: 10.1007/s10840-019-00661-5. Epub 2019 Nov 22.
- Leung LW, Gallagher MM. Esophageal cooling for protection: an innovative tool that improves the safety of atrial fibrillation ablation. Expert Rev Med Devices. 2020 Oct;17(10):981-982. doi: 10.1080/17434440.2020.1824674. Epub 2020 Sep 21.
- Zagrodzky J, Gallagher MM, Leung LWM, Sharkoski T, Santangeli P, Tschabrunn C, Guerra JM, Campos B, MacGregor J, Hayat J, Clark B, Mazur A, Feher M, Arnold M, Metzl M, Nazari J, Kulstad E. Cooling or Warming the Esophagus to Reduce Esophageal Injury During Left Atrial Ablation in the Treatment of Atrial Fibrillation. J Vis Exp. 2020 Mar 15;(157). doi: 10.3791/60733.
- Leung LWM, Gallagher MM. Letter in reply to Gianni et al on "Prevention, diagnosis, and management of atrioesophageal fistula". Pacing Clin Electrophysiol. 2020 Nov;43(11):1417-1418. doi: 10.1111/pace.14012. Epub 2020 Sep 3. No abstract available.
- Lisa Leung 2022. "Oesophageal Protection Study: A Multicentre Study.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04577859.
Frequently Asked Questions
Does this research trial have an age restriction, specifically for those over 65?
"For this clinical trial, only participants of legal age and under 85 years old can be recruited." - Anonymous Online Contributor
Is recruitment currently ongoing for this trial?
"As listed on clinicaltrials.gov, the recruitment of participants for this study is currently underway. This experimental trial was first opened to public scrutiny on March 10th 2022 and has recently been updated with new information as of February 15th 2023." - Anonymous Online Contributor
What is the aggregate number of clinical centers administering this trial?
"Several clinical trial sites are offering this medication, such as the Beth Israel Deaconess Medical Center in Boston, University of Pennsylvania in Philadelphia, and Texas Cardiac Arrhythmia Research Foundation in Austin. An additional 5 locations can also be found across America." - Anonymous Online Contributor
Can I sign up for this experiment?
"This medical trial seeks to recruit 500 individuals, aged between 18 and 85 years old, who are currently suffering from atrio-esophageal fistula. In addition, they must meet the necessary requirements for AF ablation treatment (general anaesthesia) as indicated by international standards. Moreover, participants must have already decided on undergoing this procedure prior to joining the study." - Anonymous Online Contributor
What is the current count of participants in this clinical experiment?
"This trial, managed by Advanced Cooling Therapy Inc. (Attune Medical), requires 500 patients who meet the pre-set qualifications to be recruited from a range of medical centres - such as Beth Israel Deaconess in Boston and University of Pennsylvania in Philadelphia." - Anonymous Online Contributor